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RECRUITING
NCT06049654
NA

Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

Sponsor: Fundación EPIC

View on ClinicalTrials.gov

Summary

The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.

Official title: Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2024-02-01

Completion Date

2026-11-01

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

DEVICE

NVT ALLEGRA TAVI System TF

Transcatheter aortic valve implantation of a NVT ALLEGRA TAVI System TF in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically

DEVICE

EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically

Locations (9)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario de La Paz

Madrid, Spain

Hospital Universitario Puerta De Hierro

Majadahonda, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Hospital Universitari I Politècnic de La Fe

Valencia, Spain

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Freeman Hospital

Newcastle, United Kingdom

Morriston Hospital, Swansea

Swansea, United Kingdom